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    FDA 510(k) FDA class 2 Substantially Equivalent 🇪🇸 Spain

    INSULCLOCK® v2.0 PRO

    K Number: K241803 · Decision Aug 22, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    62

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    Basic Information

    Device Name
    INSULCLOCK® v2.0 PRO
    K Number
    K241803
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Insulcloud S.L.
    Date Received
    June 21, 2024
    Decision Date
    August 22, 2024
    Product Code
    QOG
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QOG Injection Data Capture Device

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